Lilly's Retevmo (selpercatinib) demonstrated an 83% reduction in the risk of disease recurrence or death as adjuvant therapy for people with early-stage RET fusion-positive lung cancer

Rhea-AI Summary

Lilly (NYSE: LLY) reported Phase 3 LIBRETTO-432 results for Retevmo (selpercatinib) as adjuvant therapy in early-stage RET fusion-positive NSCLC. Selpercatinib cut risk of disease recurrence or death by 83% versus placebo (HR 0.17; p<0.001) and improved 24‑month event-free survival.

Positive

• Primary endpoint met: 83% lower risk of recurrence or death (HR 0.17)
• 24‑month EFS 92% vs 61% in stage II–IIIA primary analysis set
• 24‑month EFS 94% vs 70% in overall stage IB–IIIA population
• Median EFS not reached for selpercatinib vs 31.8 months for placebo
• Results consistent across central review and key subgroups
• Lilly plans submissions of LIBRETTO‑432 data to global health authorities

Negative

• Grade ≥3 ALT elevation: 17% with selpercatinib vs 1% with placebo
• Grade ≥3 AST elevation: 19% with selpercatinib vs 3% with placebo
• Overall survival data currently immature with few events observed

Market Context

This announcement highlights compelling Phase 3 LIBRETTO‑432 results, with selpercatinib cutting rec...

Analysis

This announcement highlights compelling Phase 3 LIBRETTO‑432 results, with selpercatinib cutting recurrence or death risk by 83% and delivering 24‑month EFS of 92% vs 61% on placebo in stage II–IIIA disease. It follows Lilly’s recent ASCO-focused oncology communications and broader pipeline updates. Investors may watch for regulatory submissions, how safety signals such as Grade ≥3 liver enzyme elevations evolve, and whether upcoming data across oncology and cardiometabolic programs sustains momentum.

Key Figures

Risk reduction: 83% reduction Sample size: 151 patients Dose: 160 mg twice daily +5 more

8 metrics

Risk reduction 83% reduction Risk of disease recurrence or death vs placebo in primary analysis population

Sample size 151 patients LIBRETTO-432 early-stage RET fusion-positive NSCLC trial population

Dose 160 mg twice daily Selpercatinib dosing in LIBRETTO-432 for up to three years

Event-free survival HR HR 0.17 (95% CI 0.06–0.51) Investigator-assessed EFS, stage II–IIIA primary analysis population

24-month EFS (primary) 92% vs 61% 24-month EFS selpercatinib vs placebo, stage II–IIIA population

Median EFS Not reached vs 31.8 months Median EFS selpercatinib vs placebo, primary population

ALT Grade ≥3 17% vs 1% Increased ALT in selpercatinib vs placebo groups

AST Grade ≥3 19% vs 3% Increased AST in selpercatinib vs placebo groups

Historical Context

5 past events · Latest: May 28 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
May 28	Obesity coverage expansion	Positive	+4.0%	Major PBMs agreed to cover Foundayo and Zepbound, expanding access and affordability.
May 27	Conference participation	Positive	+1.7%	Participation in Goldman Sachs healthcare conference with scheduled fireside chat webcast.
May 26	Infectious disease acquisitions	Neutral	-0.0%	Announced three vaccine-focused acquisitions to build infectious disease portfolio.
May 25	VERVE-102 clinical data	Positive	-0.0%	Phase 1b data showed large, durable LDL-C and PCSK9 reductions with favorable safety.
May 21	ASCO portfolio showcase	Positive	+2.2%	Preview of extensive ASCO data including Phase 3 Retevmo NSCLC Plenary presentation.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent news has generally produced price moves aligned with the underlying sentiment, with one notable divergence on positive clinical data.

Recent Company History

Over the last few weeks, Lilly has reported multiple catalysts across obesity, cardiometabolic, infectious disease, and oncology. Obesity coverage expansion for Foundayo and Zepbound on May 28 saw a 4.05% gain, while ASCO oncology portfolio highlights on May 21 coincided with a 2.24% rise. Positive base-editing data for VERVE-102 on May 25 produced a flat reaction. Today’s Retevmo adjuvant NSCLC data builds directly on the previously flagged ASCO Plenary focus for Retevmo.

Key Terms

adjuvant therapy, non-small cell lung cancer, event-free survival, hazard ratio, +2 more

6 terms

adjuvant therapy medical

"clinical trial of Retevmo (selpercatinib) as adjuvant therapy versus placebo in patients"

Adjuvant therapy is an extra medical treatment given after the main treatment—often surgery—to reduce the chance that a disease will come back, such as additional drugs, radiation, or immune-based treatments. For investors it matters because successful adjuvant treatments can expand the market for a drug, influence regulatory approval and reimbursement, and change revenue forecasts much like a protective follow-up step that prevents problems from reappearing.

non-small cell lung cancer medical

"RET fusion-positive non-small cell lung cancer (NSCLC). The study met its primary endpoint"

A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.

event-free survival medical

"clinically meaningful improvement in investigator-assessed event-free survival (EFS) with selpercatinib"

Event-free survival measures the length of time after a treatment or diagnosis during which a patient does not experience a predefined negative outcome, such as disease progression, relapse, or death. For investors, longer event-free survival in clinical trials signals that a therapy may be effective and durable, improving its chances of regulatory approval and commercial success — think of it like a warranty period before problems reappear.

hazard ratio medical

"EFS in the primary analysis population ... (HR: 0.17 [95% CI, 0.06 to 0.51]; p<0.001)."

A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.

blinded independent central review medical

"Results were consistent across blinded independent central review and key subgroups"

Blinded independent central review is a quality-control step in clinical trials where outside medical experts, who do not know which patients received the experimental therapy, re-examine key measurements (like scans or lab results) to prevent bias. Think of it as neutral referees watching game footage without knowing the teams, which gives investors greater confidence that the trial results are fair, more reliable for regulators, and less likely to be overturned or disputed.

adverse events medical

"The most common Grade 3 or higher adverse events (AEs) were increased alanine"

Adverse events are any harmful or unwanted medical occurrences experienced by people using a drug, device, or undergoing a treatment, whether or not the problem is caused by the product. Think of them as complaints or breakdowns noticed during a trial or after a product is on the market; regulators record and investigate them. Investors care because clusters or serious adverse events can delay approvals, trigger costly studies or recalls, change labeling, and quickly alter a company’s revenue and risk profile.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Phase 3 LIBRETTO-432 results establish RET fusions alongside EGFR mutations and ALK fusions as biomarkers in early-stage lung cancer that are associated with dramatic treatment outcomes, underscoring the importance of comprehensive biomarker testing across all stages of disease

These data will be published in the New England Journal of Medicine and simultaneously presented during the Plenary Session at the 2026 ASCO Annual Meeting

INDIANAPOLIS, May 31, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced results from the Phase 3 LIBRETTO-432 clinical trial of Retevmo (selpercatinib) as adjuvant therapy versus placebo in patients with early-stage (IB-IIIA) rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in investigator-assessed event-free survival (EFS) with selpercatinib reducing the risk of disease recurrence or death by 83% versus placebo in the primary analysis population.

These data will be simultaneously published in the New England Journal of Medicine and presented during the Plenary Session at the 2026 ASCO Annual Meeting taking place in Chicago, Illinois, as well as featured in the meeting's press program.

"Patients with early-stage RET fusion-positive lung cancer face high recurrence risk, yet unlike those with EGFR or ALK alterations, have lacked a proven targeted treatment option," said Jonathan Goldman, M.D., Professor of Medicine and Director of Clinical Trials at University of California, Los Angeles. "These LIBRETTO-432 results provide strong evidence that treating with selpercatinib after surgery or radiation can significantly lower that risk. The magnitude of benefit seen from adjuvant treatment with selpercatinib reinforces that comprehensive genomic testing at diagnosis is essential for all people with lung cancer and could lead to changes in clinical practice for treating early-stage RET-positive disease."

LIBRETTO-432 is the first and only randomized Phase 3 study to evaluate the safety and efficacy of a selective RET kinase inhibitor as adjuvant therapy in this population. The trial enrolled 151 patients who were randomized 1:1 to receive selpercatinib 160mg twice daily or placebo for up to three years following completion of definitive radiotherapy or surgery with curative intent with or without adjuvant chemotherapy.

At a median follow-up of 24 months, investigator-assessed EFS in the primary analysis population (patients with stage II-IIIA disease, n=109) was significantly improved with selpercatinib compared to placebo (HR: 0.17 [95% CI, 0.06 to 0.51]; p<0.001). The EFS rate at 24 months was 92% [95% CI, 75.4 to 97.2] for selpercatinib compared to 61% [95% CI, 44.2 to 74.3] for placebo. The median EFS was not reached for selpercatinib versus 31.8 months for placebo. In the overall study population (patients with stage IB-IIIA disease, n=151), EFS was consistent, also favoring selpercatinib (HR: 0.17 [95% CI, 0.06 to 0.49]; p<0.001). The EFS rate at 24 months was 94% [95% CI, 81.5 to 98.0] in the selpercatinib group and 70% [95% CI, 55.5 to 80.1] in the placebo group. Results were consistent across blinded independent central review and key subgroups in both the primary analysis set and in the overall study population. Overall survival results trended in favor of selpercatinib, but were immature at the time of this analysis with few events observed.

The overall safety profile of selpercatinib in LIBRETTO-432 was generally consistent with previously reported trials in the selpercatinib development program. The most common Grade 3 or higher adverse events (AEs) were increased alanine aminotransferase (ALT) (17% in the selpercatinib group versus 1% in the placebo group) and increased aspartate aminotransferase (AST) (19% in the selpercatinib group versus 3% in the placebo group), but were manageable with dose-modification.

"Selpercatinib has changed the treatment paradigm for patients with advanced RET-positive lung cancer, and now the substantial reduction in the risk of recurrence or death seen in LIBRETTO-432 highlights the potential for it to also become a new standard of care in the adjuvant setting for patients with early-stage RET-positive NSCLC," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "These compelling results highlight the importance of bringing our effective medicines to patients early in their disease course when their impact can be greatest, and bring further urgency to the need for comprehensive biomarker testing for all lung cancers at diagnosis to enable effective therapy against EGFR, ALK and RET and for the development of medicines targeting emerging new biomarkers."

Lilly plans to submit results from LIBRETTO-432 to global health authorities. For more information on the LIBRETTO Phase 3 clinical trial program, please visit clinicaltrials.gov.

About LIBRETTO-432
LIBRETTO-432 is a Phase 3, global, multicenter, randomized, double-blind, controlled clinical trial of selpercatinib versus placebo in patients with RET fusion-positive NSCLC following completion of definitive radiotherapy or surgery with curative intent, and other adjuvant therapy, if indicated. The trial enrolled 151 patients who were randomized 1:1 to receive either selpercatinib or placebo as adjuvant therapy for RET fusion-positive NSCLC. The primary endpoint is EFS as assessed by investigator in the primary analysis population, which was comprised of patients with stage II-IIIA RET fusion-positive NSCLC. Secondary endpoints include EFS as assessed by investigator in the overall population, overall survival (OS), EFS as assessed by blinded independent central review (BICR), time to distant disease recurrence in the central nervous system (CNS) as assessed by investigator and BICR, progression-free survival on the next line of treatment (PFS2), positive predictive value (PPV) of RET tests from investigator-identified laboratories with respect to the Lilly-designated RET test, safety and tolerability.

About Retevmo 
Retevmo (selpercatinib, formerly known as LOXO-292) (pronounced reh-TEHV-moh) is a highly selective and potent RET kinase inhibitor with central nervous system (CNS) activity. Retevmo may affect both tumor cells and healthy cells, which can result in side effects. RET-driver alterations are predominantly mutually exclusive from other oncogenic drivers. Retevmo is a U.S. FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (<50 kg or ≥50 kg, respectively), taken twice daily until disease progression or unacceptable toxicity.¹

INDICATIONS FOR RETEVMO (selpercatinib)

RETEVMO is a kinase inhibitor indicated for the treatment of:

• Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test

IMPORTANT SAFETY INFORMATION FOR RETEVMO (selpercatinib)

Hepatotoxicity: Serious hepatic adverse reactions occurred in 3% of patients treated with Retevmo. Increased aspartate aminotransferase (AST) occurred in 59% of patients, including Grade 3 or 4 events in 11% and increased alanine aminotransferase (ALT) occurred in 55% of patients, including Grade 3 or 4 events in 12%. Monitor ALT and AST prior to initiating Retevmo, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce dose, or permanently discontinue Retevmo based on severity.

Severe, life-threatening, and fatal interstitial lung disease (ILD)/pneumonitis can occur in patients treated with Retevmo. ILD/pneumonitis occurred in 1.8% of patients who received Retevmo, including 0.3% with Grade 3 or 4 events, and 0.3% with fatal reactions. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold Retevmo and promptly investigate for ILD in any patient who presents with acute or worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Withhold, reduce dose, or permanently discontinue Retevmo based on severity of confirmed ILD.

Hypertension occurred in 41% of patients, including Grade 3 hypertension in 20% and Grade 4 in one (0.1%) patient. Overall, 6.3% had their dose interrupted and 1.3% had their dose reduced for hypertension. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. Do not initiate Retevmo in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating Retevmo. Monitor blood pressure after 1 week, at least monthly thereafter, and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue Retevmo based on severity.

Retevmo can cause concentration-dependent QT interval prolongation. An increase in QTcF interval to >500 ms was measured in 7% of patients and an increase in the QTcF interval of at least 60 ms over baseline was measured in 20% of patients. Retevmo has not been studied in patients with clinically significant active cardiovascular disease or recent myocardial infarction. Monitor patients who are at significant risk of developing QTc prolongation, including patients with known long QT syndromes, clinically significant bradyarrhythmias, and severe or uncontrolled heart failure. Assess QT interval, electrolytes, and thyroid-stimulating hormone (TSH) at baseline and periodically during treatment, adjusting frequency based upon risk factors including diarrhea. Correct hypokalemia, hypomagnesemia, and hypocalcemia prior to initiating Retevmo and during treatment. Monitor the QT interval more frequently when Retevmo is concomitantly administered with strong and moderate CYP3A inhibitors or drugs known to prolong QTc interval. Withhold and dose reduce or permanently discontinue Retevmo based on the severity.

Serious, including fatal, hemorrhagic events can occur with Retevmo. Grade ≥3 hemorrhagic events occurred in 3.1% of patients treated with Retevmo including 4 (0.5%) patients with fatal hemorrhagic events, including cerebral hemorrhage (n=2), tracheostomy site hemorrhage (n=1), and hemoptysis (n=1). Permanently discontinue Retevmo in patients with severe or life-threatening hemorrhage.

Retevmo can cause hypersensitivity, including severe skin reactions such as Stevens-Johnson Syndrome. All grade hypersensitivity occurred in 6% of patients receiving Retevmo, including Grade 3 in 1.9%. The median time to onset was 1.9 weeks (range: 5 days to 2 years). Signs and symptoms of hypersensitivity included fever, rash and arthralgias or myalgias with concurrent decreased platelets or transaminitis. Stevens-Johnson Syndrome has been observed in the post-marketing setting. Discontinue Retevmo in patients with Stevens-Johnson Syndrome. If hypersensitivity occurs, withhold Retevmo and begin corticosteroids at a dose of 1 mg/kg prednisone (or equivalent). Upon resolution of the event, resume Retevmo at a reduced dose and increase the dose of Retevmo by 1 dose level each week as tolerated until reaching the dose taken prior to onset of hypersensitivity. Continue steroids until patient reaches target dose and then taper. Permanently discontinue Retevmo for recurrent hypersensitivity.

Tumor lysis syndrome (TLS) occurred in 0.6% of patients with medullary thyroid carcinoma receiving Retevmo. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated.

Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, Retevmo has the potential to adversely affect wound healing. Withhold Retevmo for at least 7 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of Retevmo after resolution of wound healing complications has not been established.

Retevmo can cause hypothyroidism. Hypothyroidism occurred in 13% of patients treated with Retevmo; all reactions were Grade 1 or 2. Hypothyroidism occurred in 13% of patients (50/373) with thyroid cancer and 13% of patients (53/423) with other solid tumors including NSCLC. Monitor thyroid function before treatment with Retevmo and periodically during treatment. Treat with thyroid hormone replacement as clinically indicated. Withhold Retevmo until clinically stable or permanently discontinue Retevmo based on severity.

Based on data from animal reproduction studies and its mechanism of action, Retevmo can cause fetal harm when administered to a pregnant woman. Administration of selpercatinib to pregnant rats during organogenesis at maternal exposures that were approximately equal to those observed at the recommended human dose of 160 mg twice daily resulted in embryolethality and malformations. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Retevmo and for 1 week after the last dose. There are no data on the presence of selpercatinib or its metabolites in human milk or on their effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with Retevmo and for 1 week after the last dose.

Severe adverse reactions (Grade 3-4) occurring in ≥20% of patients who received Retevmo in LIBRETTO-001, were hypertension (20%), diarrhea (5%), prolonged QT interval (4.8%), dyspnea (3.1%), fatigue (3.1%), hemorrhage (2.6%), abdominal pain (2.5%), vomiting (1.8%), headache (1.4%), nausea (1.1%), constipation (0.8%), edema (0.8%), rash (0.6%), and arthralgia (0.3%).

Severe adverse reactions (Grade 3-4) occurring in ≥15% of patients who received Retevmo or chemotherapy with or without pembrolizumab in LIBRETTO-431 were hypertension (20% vs 3.1%), electrocardiogram QT prolonged (9% vs 0%), fatigue (3.2% vs 5%), edema (2.5% vs 0%), rash (1.9% vs 1.0%), diarrhea (1.3% vs 2.0%), abdominal pain (0.6% vs 2.0%), pyrexia (0.6% vs 0%), COVID19 infection (0.6% vs 0%), constipation (0% vs 1.0%), nausea (0% vs 1.0%), vomiting (0% vs 1.0%), and decreased appetite (0% vs 2.0%).

Serious adverse reactions occurred in 44% of patients who received Retevmo in LIBRETTO-001. The most frequently reported serious adverse reactions (in ≥2% of patients) were pneumonia, pleural effusion, abdominal pain, hemorrhage, hypersensitivity, dyspnea, and hyponatremia. Fatal adverse reactions occurred in 3% of patients in LIBRETTO-001; fatal adverse reactions included sepsis (n=6), respiratory failure (n=5), hemorrhage (n=4), pneumonia (n=3), pneumonitis (n=2), cardiac arrest (n=2), sudden death (n=1), and cardiac failure (n=1).

Serious adverse reactions occurred in 35% of patients who received Retevmo in LIBRETTO-431. The most frequently reported serious adverse reactions (≥2% of patients) were pleural effusion and abnormal hepatic function. Fatal adverse reactions occurred in 4.4% of patients who received Retevmo in LIBRETTO-431; fatal adverse reactions included myocardial infarction (n=2), respiratory failure (n=2), cardiac arrest, malnutrition, and sudden death (n=1 each).

Common adverse reactions (all grades) occurring in ≥20% of patients who received Retevmo in LIBRETTO-001, were edema (49%), diarrhea (47%), fatigue (46%), dry mouth (43%), hypertension (41%), abdominal pain (34%), rash (33%), constipation (33%), nausea (31%), headache (28%), cough (24%), vomiting (22%), dyspnea (22%), hemorrhage (22%), arthralgia (21%), and prolonged QT interval (21%).

Common adverse reactions (all grades) occurring in ≥15% of patients who received Retevmo or chemotherapy with or without pembrolizumab in LIBRETTO-431 were hypertension (48% vs 7%), diarrhea (44% vs 24%), edema (41% vs 28%), dry mouth (39% vs 6%), rash (33% vs 30%), fatigue (32% vs 50%), abdominal pain (25% vs 19%), musculoskeletal pain (25% vs 28%), constipation (22% vs 40%), electrocardiogram QT prolonged (20% vs 1.0%), COVID19 infection (19% vs 18%), stomatitis (18% vs 16%), decreased appetite (17% vs 34%), nausea (13% vs 44%), vomiting (13% vs 23%), and pyrexia (13% vs 23%).

Laboratory abnormalities (all grades ≥20%; Grade 3-4) worsening from baseline in patients who received Retevmo in LIBRETTO-001, were increased AST (59%; 11%), decreased calcium (59%; 5.7%), increased ALT (56%; 12%), decreased albumin (56%; 2.3%), increased glucose (53%; 2.8%), decreased lymphocytes (52%; 20%), increased creatinine (47%; 2.4%), decreased sodium (42%; 11%), increased alkaline phosphatase (40%; 3.4%), decreased platelets (37%; 3.2%), increased total cholesterol (35%; 1.7%), increased potassium (34%; 2.7%), decreased glucose (34%; 1.0%), decreased magnesium (33%; 0.6%), increased bilirubin (30%; 2.8%), decreased hemoglobin (28%; 3.5%), and decreased neutrophils (25%; 3.2%).

Laboratory abnormalities (all grades ≥20%; Grade 3-4) worsening from baseline in patients who received Retevmo or chemotherapy with or without pembrolizumab in LIBRETTO-431 were increased ALT (81%; 21% vs 63%; 4.1%), increased AST (77%; 10% vs 46%; 0%), decreased calcium (53%; 1.9% vs 24%; 1.0%), decreased platelets (53%; 3.2% vs 39%; 5%), decreased lymphocytes (53%; 8% vs 64%; 15%), decreased neutrophils (53%; 2.0% vs 58%; 11%), increased bilirubin (52%; 1.3% vs 9%; 0%), increased alkaline phosphatase (35%; 1.3% vs 22%; 0%), decreased sodium (31%; 3.2% vs 41%; 2.1%), decreased albumin (25%; 0% vs 5%; 0%), increased blood creatinine (23%; 0% vs 21%; 0%), decreased hemoglobin (21%; 0% vs 91%; 5%), decreased potassium (17%; 1.3% vs 15%; 1.0%), and decreased magnesium (16%; 0.6% vs 8%; 0%).

Concomitant use of acid-reducing agents decreases selpercatinib plasma concentrations which may reduce Retevmo anti-tumor activity. Avoid concomitant use of proton-pump inhibitors (PPIs), histamine-2 (H2) receptor antagonists, and locally acting antacids with Retevmo. If coadministration cannot be avoided, take Retevmo with food (with a PPI) or modify its administration time (with a H2 receptor antagonist or a locally acting antacid).

Concomitant use of strong and moderate CYP3A inhibitors increases selpercatinib plasma concentrations which may increase the risk of Retevmo adverse reactions including QTc interval prolongation. Avoid concomitant use of strong and moderate CYP3A inhibitors with Retevmo. If concomitant use of a strong or moderate CYP3A inhibitor cannot be avoided, reduce the Retevmo dosage as recommended and monitor the QT interval with ECGs more frequently.

Concomitant use of strong and moderate CYP3A inducers decreases selpercatinib plasma concentrations which may reduce Retevmo anti-tumor activity. Avoid coadministration of Retevmo with strong and moderate CYP3A inducers.

Concomitant use of Retevmo with CYP2C8 and CYP3A substrates increases their plasma concentrations which may increase the risk of adverse reactions related to these substrates. Avoid coadministration of Retevmo with CYP2C8 and CYP3A substrates where minimal concentration changes may lead to increased adverse reactions. If coadministration cannot be avoided, follow recommendations for CYP2C8 and CYP3A substrates provided in their approved product labeling.

Retevmo is a P-glycoprotein (P-gp) and BCRP inhibitor. Concomitant use of Retevmo with P-gp or BCRP substrates increases their plasma concentrations, which may increase the risk of adverse reactions related to these substrates. Avoid coadministration of Retevmo with P-gp or BCRP substrates where minimal concentration changes may lead to increased adverse reactions. If coadministration cannot be avoided, follow recommendations for P-gp and BCRP substrates provided in their approved product labeling.

No dosage modification is recommended for patients with mild to severe renal impairment (estimated Glomerular Filtration Rate [eGFR] ≥15 to 89 mL/min, estimated by Modification of Diet in Renal Disease [MDRD] equation). A recommended dosage has not been established for patients with end-stage renal disease.

Reduce the dose when administering Retevmo to patients with severe hepatic impairment (total bilirubin greater than 3 to 10 times upper limit of normal [ULN] and any AST). No dosage modification is recommended for patients with mild or moderate hepatic impairment. Monitor for Retevmo-related adverse reactions in patients with hepatic impairment.

Retevmo (selpercatinib) is available as 40 mg and 80 mg capsules, and 40 mg, 80 mg, 120 mg, and 160 mg tablets.

SE HCP ISI LA_NOV2025

Please see full Prescribing Information, including Instructions for Use, for Retevmo.

About Lilly           
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY

© Lilly USA, LLC 2026. ALL RIGHTS RESERVED. 

Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

Cautionary Statement Regarding Forward-Looking Statements 
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Retevmo as a potential treatment for rearranged during transfection (RET) fusion-positive stage IB-IIIA NSCLC following completion of definitive radiotherapy or surgery with curative intent, and other adjuvant therapy if indicated, and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, or that Retevmo will receive additional regulatory approvals. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. 
 
Endnotes & References 

1. Retevmo. Prescribing information. Lilly USA, LLC.

Refer to:	Kyle Owens; owens_kyle@lilly.com; (332) 259-3932 (Media)
	Michael Czapar; czapar_michael_c@lilly.com; (317) 617-0983 (Investors)

View original content to download multimedia:https://www.prnewswire.com/news-releases/lillys-retevmo-selpercatinib-demonstrated-an-83-reduction-in-the-risk-of-disease-recurrence-or-death-as-adjuvant-therapy-for-people-with-early-stage-ret-fusion-positive-lung-cancer-302786427.html

SOURCE Eli Lilly and Company

FAQ

What did Lilly (LLY) announce about Retevmo in the Phase 3 LIBRETTO-432 trial?

Lilly announced that Retevmo significantly improved event-free survival as adjuvant therapy in early-stage RET fusion-positive NSCLC. According to Lilly, selpercatinib reduced the risk of disease recurrence or death by 83% versus placebo, meeting the trial’s primary endpoint in the primary analysis population.

How much did Retevmo (selpercatinib) reduce recurrence risk in early-stage RET-positive NSCLC?

Retevmo reduced the risk of disease recurrence or death by 83% compared with placebo. According to Lilly, this corresponds to a hazard ratio of 0.17 in the primary analysis population, with p<0.001, indicating a highly statistically significant event-free survival benefit for early-stage RET fusion-positive NSCLC.

What were the 24-month event-free survival rates in LIBRETTO-432 for Retevmo versus placebo?

At 24 months, event-free survival was higher with Retevmo than placebo in LIBRETTO-432. According to Lilly, EFS was 92% vs 61% in stage II–IIIA patients and 94% vs 70% in the overall stage IB–IIIA population, both favoring selpercatinib.

What safety profile did Retevmo show in Lilly’s LIBRETTO-432 adjuvant lung cancer trial?

Retevmo’s overall safety profile was generally consistent with earlier studies in its development program. According to Lilly, the most common Grade 3 or higher adverse events were increased ALT (17% vs 1% placebo) and increased AST (19% vs 3% placebo), described as manageable with dose modification.

Did LIBRETTO-432 show an overall survival benefit for Retevmo in early-stage RET-positive NSCLC?

Overall survival in LIBRETTO-432 currently trends in favor of Retevmo but remains immature. According to Lilly, few survival events had occurred at the time of analysis, so event-free survival forms the main evidence for benefit in early-stage RET fusion-positive NSCLC.

How many patients were enrolled in Lilly’s LIBRETTO-432 trial of Retevmo and how was it designed?

LIBRETTO-432 enrolled 151 patients with stage IB–IIIA RET fusion-positive NSCLC after curative-intent therapy. According to Lilly, participants were randomized 1:1 to selpercatinib 160 mg twice daily or placebo for up to three years following surgery or radiotherapy, with or without adjuvant chemotherapy.

What are Lilly’s next regulatory steps after the LIBRETTO-432 Retevmo results?

Lilly plans to submit LIBRETTO-432 results to global health authorities for review. According to Lilly, the Phase 3 findings may support use of selpercatinib as adjuvant therapy in early-stage RET fusion-positive NSCLC and emphasize comprehensive biomarker testing at lung cancer diagnosis.